Irinotecan Hydrochloride Concentrate for Soln for Inf 20mg/ml (2ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

Available from:

Accord Healthcare Limited

ATC code:

L01XX19

INN (International Name):

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Patient Information leaflet

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Version No.
Date
-
Accord
Irinotecan
UK-IE-MT
English
300 x 500 mm PIL
9
4 (Page 1 of 2)
12/04/17 (Irinotecan (ACC-UK-IE-MT)-PIL)
Colours Used
Pantone Black
Prepared By
Regulatory Affairs
Checked By
Regulatory Affairs
Approved By
Quality Assurance
PACKAGE LEAFLET: INFORMATION FOR THE USER
Irinotecan Hydrochloride
20 mg/ml Concentrate for
Solution for Infusion
irinotecan hydrochloride trihydrate
The name of your medicine is ‘Irinotecan Hydrochloride
20 mg/ml Concentrate for Solution for Infusion’ but in the rest
of the leaflet it will be called “Irinotecan Injection”.
Read all of this leaflet carefully before you start using this
medicine.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
•
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1. What Irinotecan Injection is and what it is used for
2. What you need to know before you are given Irinotecan
Injection
3. How you will be given Irinotecan Injection
4. Possible side effects
5. How to store Irinotecan Injection
6. Contents of the pack and other information 1. WHAT IRINOTECAN INJECTION IS AND WHAT IT
IS USED FOR
Irinotecan belongs to a group of medicines called cytostatics
(anti-cancer medicines). Irinotecan is used for the treatment of
advanced cancer of the colon and rectum in adults, either in a
combination with other medicines or alone.
Your doctor may use a combination of Irinotecan with
5-FLUOROURACIL/FOLINIC ACID (5FU/FA) and BEVACIZUMAB to
treat your CANCER OF THE LARGE INTESTINE (COLON OR RECTUM).
Your doctor may use a combination of Irinotecan with
CAPECITABINE with or without BEVACIZUMAB to treat your
CANCER OF THE COLON AND RECTUM.
Your doctor may use a combination of Irinotecan wi

Summary of Product characteristics

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for
Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 20 mg irinotecan hydrochloride
trihydrate equivalent to 17.33 mg
irinotecan.
Each vial of 2 ml contains 40 mg of irinotecan hydrochloride
trihydrate (40 mg/2 ml)
Each vial of 5 ml contains 100 mg of irinotecan hydrochloride
trihydrate (100 mg/5 ml)
Each vial of 15 ml contains 300 mg of irinotecan hydrochloride
trihydrate (300 mg/15 ml)
Each vial of 25 ml contains 500 mg of irinotecan hydrochloride
trihydrate (500 mg/25 ml)
Excipient with known effect
Each ml contains 45 mg sorbitol.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A pale yellow clear solution practically free from particles. pH in
the range of approximately 3.0 to
3.8 and osmolality in the range of approximately 270 to 330 mOsmol/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irinotecan
Hydrochloride 20 mg/ml Concentrate for
Solution for
Infusion
is
indicated
for
the
treatment of patients with advanced colorectal cancer:

In combination with 5-fluorouracil and folinic acid in patients
without prior chemotherapy for
advanced disease,

As a single agent in patients who have failed an established
5-fluorouracil containing
treatment regimen.
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for
Infusion in combination with
cetuximab is indicated for the treatment of patients with epidermal
growth factor receptor (EGFR)-
expressing, KRAS wild- type metastatic colorectal cancer, who had not
received prior treatment for
metastatic disease or after failure of irinotecan-including cytotoxic
therapy. (see section 5.1)
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for
Infusion in combination with 5-
fluorouracil, folinic acid and bevacizumab is indicated for first-line
treatment of patients with
metastatic carcinoma of the colon or rectum.
P